Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-01-03 @ 5:54 PM
Study NCT ID:
NCT05839561
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monotherapy With Letrozole in Tubal Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011274', 'term': 'Pregnancy, Tubal'}], 'ancestors': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-04-15', 'studyFirstSubmitQcDate': '2023-04-29', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of the treatment', 'timeFrame': 'up to 6 months', 'description': 'Conversion rate to laparoscopy due to tubal rupture, pain, serum B-hCG increase in the course of treatment'}], 'secondaryOutcomes': [{'measure': 'The effect of treatment on bone marrow function (hemoglobin)', 'timeFrame': 'up to 6 months', 'description': 'Changes in hemoglobin concentration (g/dl) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on bone marrow function (red blood cells)', 'timeFrame': 'up to 6 months', 'description': 'Changes in red blood cell count (T/l) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on bone marrow function (white blood cells)', 'timeFrame': 'up to 6 months', 'description': 'Changes in white blood count (G/l) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on bone marrow function (platelets)', 'timeFrame': 'up to 6 months', 'description': 'Changes in platelet count (G/l) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on liver function (total bilirubin)', 'timeFrame': 'up to 6 months', 'description': 'Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on liver function (alanine transaminase)', 'timeFrame': 'up to 6 months', 'description': 'Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on liver function (aspartate transaminase)', 'timeFrame': 'up to 6 months', 'description': 'Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on liver function (gamma-glutamyltransferase)', 'timeFrame': 'up to 6 months', 'description': 'Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on kidney function (urea)', 'timeFrame': 'up to 6 months', 'description': 'Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7)'}, {'measure': 'The effect of treatment on kidney function (creatinine)', 'timeFrame': 'up to 6 months', 'description': 'Changes in the concentrations of serum creatinine (mg/dl) in the course of treatment (day 0,4,7)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tubal pregnancy', 'Methotrexate', 'Letrozole'], 'conditions': ['Tubal Pregnancy Unruptured']}, 'descriptionModule': {'briefSummary': 'It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (MTX) in women refusing surgery. The aim was to compare the effectiveness of letrozole with MTX in the management of tubal pregnancy.', 'detailedDescription': 'A prospective cohort study is conducted among women with tubal pregnancy. Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included.\n\nTwo study arms were planned:\n\ni) women treated with MTX: MTX in a single dose of 100 mg intravenously on day 0; ii) women treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0.\n\nThe inclusion criteria included B-hCG concentration up to 3000 mIU/ml and no contraindications to conservative treatment. Women who did not meet criteria for conservative treatment were excluded. Blood parameters (B-hCG, hemoglobin, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7. Cases of treatment failure were counted, i.e. the need to perform laparoscopy due to tubal pregnancy rupture, pain, increase in B-hCG concentration.\n\nThe women were given the option to choose the treatment used in the study. All enrolled women gave informed written consent to participate in the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tubal pregnancy confirmed on pelvic ultrasound\n* increasing serum B-hCG concentrations in at least two subsequent measures\n* serum B-hCG concentration ≤ 3000 mIU/ml\n\nExclusion Criteria:\n\n* free fluid in lesser pelvis on pelvic ultrasound\n* positive fetal heartbeat on pelvic ultrasound\n* abdominal pain\n* heterotopic pregnancy\n* contraindications to MTX'}, 'identificationModule': {'nctId': 'NCT05839561', 'briefTitle': 'Monotherapy With Letrozole in Tubal Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Management of Tubal Pregnancy With Off-label Use of Letrozole in Monotherapy', 'orgStudyIdInfo': {'id': '1072.6120.321.2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tubal pregnancy treated with MTX', 'description': 'MTX in a single dose of 100 mg intravenously on day 0', 'interventionNames': ['Drug: MTX as monotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tubal pregnancy treated with letrozole', 'description': 'Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0', 'interventionNames': ['Drug: Letrozole as monotherapy']}], 'interventions': [{'name': 'Letrozole as monotherapy', 'type': 'DRUG', 'description': 'Letrozole 5 mg daily orally for 10 days from day 0', 'armGroupLabels': ['Tubal pregnancy treated with letrozole']}, {'name': 'MTX as monotherapy', 'type': 'DRUG', 'description': 'MTX in a single dose of 100 mg intravenously on day 0', 'armGroupLabels': ['Tubal pregnancy treated with MTX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Robert Jach, Prof., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Jagiellonian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D., Principal Investigator', 'investigatorFullName': 'Iwona Magdalena Gawron', 'investigatorAffiliation': 'Jagiellonian University'}}}}